_IB2731 Development of MCMs and BD- RFP.pdf

SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: 96-83

2. Request for Proposal Number:

BAA-75N93026R00004

3. Issue Date:

2/10/2026

4. Set Aside:

[X] No

[] Yes See Part IV Section L

5. Title: Development of Radiological/Nuclear Medical Countermeasures (MCMs) And Biodosimetry Devices

6. ISSUED BY:

Office of Acquisitions

National Institute of Allergies and Infectious Disease

National Institutes of Health

5601 Fishers Lane

Room 3D10

Rockville, MD 20952

7. SUBMIT OFFERS TO:

See Part III, Section J, "Packaging and Delivery of the Proposal,"

ATTACHMENT 1 of this Solicitation.

Any solicitation questions must be submitted on or before 3/03/2026.

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposal," until 3:00 pm Eastern Time on 5/04/2026. Offers will be valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

9. This solicitation requires delivery of proposals as stated in ATTACHMENT 1, "PACKAGING AND DELIVERY

OF THE PROPOSAL." If proposals are required to be delivered to two different locations, the OFFICIAL POINT

OF RECEIPT for determining TIMELY DELIVERY is the address provided for the OFFICE OF ACQUISITIONS.

IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS DESIGNEE AT THE

PLACE AND TIME SPECIFIED FOR THE OFFICE OF ACQUISITIONS, THEN IT WILL BE CONSIDERED

LATE AND HANDLED IN ACCORDANCE WITH subparagraph (c)(3) of FAR Clause 52.215-1, Instructions to

Offerors--Competitive Acquisition," LOCATED IN SECTION L.1. OF THIS SOLICITATION.

10. Offeror must be registered in the System for Award Management (SAM) prior to award of a contract. Offerors must access the CCR through The System for Award Management (SAM) at http://www.sam.gov

11. FOR INFORMATION CALL: Lisa Anglin

PHONE: 240-292-4402

e-MAIL:lisa.anglin@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

We strongly suggest that any questions regarding the solicitation be submitted by 3:00 PM EST, on March 3, 2026, so that we can provide timely responses before proposals are due.

Lisa Anglin

Contract Specialist

Office of Acquisitions

National Institutes of Allergy and Infectious

Disease http://www.sam.gov/ mailto:lisa.anglin@nih.gov

SECTION B - SUPPLIES OR SERVICES/PRICES

1. Brief Description of Supplies or Services

2. Estimated Cost - Option

3. Provisions Applicable to Direct Costs …………....….……………………………………………………5

4. Advance Understandings……..…….…………………………………………………………………………..5

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

1. Statement of Work……………………………………………………………………………..………….….…...7

2. Reporting Requirements

3. Invention Reporting Requirement

SECTION D - PACKAGING, MARKING, AND SHIPPING

SECTION E – INSPECTION AND ACCEPTANCE

SECTION F – DELIVERIES OR PERFORMANCE

1. Period of Performance

2. Deliveries……………………………………………………………………………………………………………….13

3. FAR 52.252-2 Clauses Incorporated by Reference. (FEB 1998)

SECTION G – CONTRACT ADMINISTRATION DATA

1. Contracting Officer Representative (COR)

2. Key Personnel

3. Invoice Submission/Contract Fianancing Request and Contract Financial Report ... 15

4. FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors.

(MAR 2023)………………………………………………………………………………....……………………………17

5. Indirect Cost Rates

6. Post Award Evaluation of Contractor Performance …………………………………………..…..18

7. Government Property ………………………………………………………………………………………..….19

SECTION H - SPECIAL CONTRACTS REQUIREMENTS

1. Protection of Human Subjects

2. Required Education in the Protection of Human Research Participants

3. Certificate of Confidentiality

4. Inclusion of Women and Minorities in Research involving Human Subjects

5. Inclusion of Individuals across the Lifespan as Participants in Research involving Human Subjects

BAA 75N93026R00004

6. Posting Clinical Trial Informed Consent Forms to Clinicaltrials.gov

7. Human Materials

8. Human Materials (Assurance of OHRP Complaince)

9. Public Health Surveillance Exclusion

10. NIH Policy on Enhancing Reproducibility through Rigor and Transparency

11. NIH Public Access Policy

12. Needle Exchange

13. Acknowledge of Federal Funding

14. Continued Ban in Funding Abortion and Continued Ban on Funding Embryo Research

15. Limited on Use of Funds for Promotion of Legalization of Controlled Substances. 28

16. Dissemination of False or Deliberately Misleading Information

17. Care of Live Vertebrate Animals

18. Animal Welfare

19. Introduction of Rodents and Rodent Products……………………………………………………..29

20. Protection of Personnel Who Work with Nonhuman Primates

21. OMB Clearance

22. Restriction on Pornography on Computer Networks

23. Gun Control

24. Option Provision

25. Subcontracting Provisions

26. Information and Communication Technology Accessibility Notice……………………….32

27. Information and Communication Technology Accessibility……………………………….….33

28. Responsibilities of Institutions regarding Investigator Financial Conflicts of Interest……………………………………………………………………………………………………………………..34

29. Publication and Publicity

30. Advianced Copies of Press Releases

31. Reporting Matters Involving Fraud, Waste, and Abuse………………………………….…….44

32. Obtaining and Disseminating Biomedical Research Resources

33. Sharing Research Data …………………………………………………………………………………………44

34. Hotel and Motel Fire Safety………………………………………………………………………………….45

35. Prohibition on Contractor Involvement with Terrorist Activities…………………………..46

36. Use of Funds for Conferences, Meetings and Food……………………………………………….46

SECTION I – CONTRACT CLAUSES………………………………………………………………………………

1. General Clauses………………………………………………………………………………………………………47

2. Authorized Substitution of Clauses…………………………………………………………………………48

3. Additional Contract Clauses in Full Text………………………………………………………………….48

4. Additional FAR Contract Clauses included in Full Text…………………………………………….50

SECTION J - List of Documents, Exhibits and Other Attachments…………………………………53

SECTION K - Representations, Certifications, and Other Statements of Bidders………….56

SECTION L - Instructions, Conditions, and Notices to Bidders……………………………………...57

SECTION M - Evaluation Factors for Award………………………………………………………………..120

PART I - THE SCHEDULE

THE INFORMATION SET FORTH IN SECTION A - SOLICITATION/CONTRACT FORM, HEREIN CONTAINS IMPORTANT INFORMATION FOR ANY OFFEROR INTERESTED IN RESPONDING TO THIS SOLICITATION. ANY

CONTRACT RESULTING FROM THIS SOLICITATION WILL INCLUDE IN ITS SECTION A -

SOLICITATION/CONTRACT FORM, ACCOUNTING, APPROPRIATION AND GENERAL INFORMATION APPLICABLE

TO THE CONTRACT AWARD.

THE CONTRACT SCHEDULE SET FORTH IN SECTIONS B THROUGH H, HEREIN, CONTAINS CONTRACTUAL INFORMATION PERTINENT TO THIS SOLICITATION. IT IS NOT AN EXACT REPRESENTATION OF THE CONTRACT DOCUMENT THAT WILL BE AWARDED AS A RESULT OF THIS SOLICITATION. THE CONTRACT COST OR PRICE AND OTHER CONTRACTUAL PROVISIONS PERTINENT TO THE OFFEROR (i.e., those relating to the organizational structure [e.g., Non-Profit, Commercial] and specific cost authorizations unique to the Offeror's proposal and requiring Contracting Officer Prior Approval) WILL BE DISCUSSED IN THE NEGOTIATION PROCESS AND WILL BE INCLUDED IN THE RESULTANT CONTRACT. THE ENCLOSED CONTRACT SCHEDULE IS INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY INFORMATION TO UNDERSTAND THE TERMS

AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - Supplies or Services/Prices

1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The goals of this BAA are two-fold. The first goal is to support the development of safe and effective MCMs to mitigate and/or treat normal tissue injuries arising from exposure to ionizing radiation from a radiological or nuclear incident, thereby leading to a reduction in radiation-associated mortality and/or major morbidities.

MCMs are not expected to be effectively mobilized for use within the first day; therefore, MCMs must be efficacious 24 hours or later post-exposure (except as noted below). The second goal is to support advancement of biodosimetry biomarkers and/or devices to inform triage and treatment strategies for use during a radiation public health emergency. Proposals must address one goal only; if the offeror intends to address both goals, two separate proposals must be submitted—one addressing MCM development and the other addressing biodosimetry.

2. ESTIMATED COST - OPTION

a. The estimated cost of the Base Period of this contract is $ TBD.

b. The fixed fee for the Base Period of this contract is $ TBD. The fixed fee shall be paid in installments based on the percentage of completion of work, as determined by the Contracting Officer. Payment shall be subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE I.1. of this contract.

c. The total estimated amount of the contract, represented by the sum of the estimated cost plus the fixed fee for the Base Period is $ TBD.

d. If the Government exercises its option pursuant to the OPTION PROVISION Article in SECTION H of this contract, the Government's total estimated contract amount represented by the sum of the estimated cost plus the fixed fee will be increased as follows:

Estimated

Cost ($) Fixed Fee

Estimated Cost Plus

Fixed Fee ($)

Base period TBD TBD TBD

Option Period 1 TBD TBD TBD

Option Period 2 TBD TBD TBD

Total Base Period and Option(s) TBD TBD TBD

3. PROVISIONS APPLICABLE TO DIRECT COSTS

This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer. The following is a list of items that may be included in the resultant contract as applicable. 1) Conferences & Meetings, 2) Food for Meals, Light Refreshments & Beverages, 3) Promotional Items, 4) Acquisition, by purchase or lease, of any interest in real property; 5) Special rearrangement or alteration of facilities; 6) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 7) Travel Costs including Foreign Travel; 8) Consultant Costs; 9) Subcontract Costs; 10) Patient Care Costs; 11) Accountable Government Property; 12) Printing costs; and 13) Research Funding.

4. ADVANCE UNDERSTANDINGS

Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award.

"Confidential Information" is scientific, business, or financial information provided by the Supplier or the NIAID Contract Officer's Representative (COR) and marked "Confidential." Oral Disclosures of Confidential Information will be reduced to writing, marked "Confidential;" and sent to Contractor within 10 days of disclosure to be considered Confidential Information. Confidential Information may not be revealed without written permission from the COR. Similarly, designated Materials are to be considered confidential. In cases where it is not clear whether information or Materials are to be considered confidential, the Contractor should contact the COR to obtain a determination. All materials supplied to the Contractor shall be utilized solely for contract-related research purposes and no unauthorized use or distribution of these materials shall be permitted.

Any Publication containing data generated under this contract ("Results") must be submitted for review by the COR and Supplier before submission for public presentation or publication. A "Publication" is defined as an issue of printed material offered for distribution or any communication or oral presentation of information, for example a manuscript or abstract. The purpose of this review is to ensure that Publications do not contain any of NIAID's or Supplier's proprietary Confidential Information and to allow Supplier time to file patent applications, if so desired. Contract support shall be acknowledged in all Publications of Results.

The COR and Supplier will review all Publications containing Results submitted to the COR and Supplier in a period of time not to exceed 120 calendar days from receipt of Results by both the COR and Supplier, and will either agree to the publication/disclosure, recommend changes and, as applicable, refer the document to the Supplier of the compound for their review. Publication of results earlier than 120 days after submission will require Supplier's written approval. When the Supplier does not consent to publication of the manuscript or abstract on the basis that Supplier's Confidential Information is included in the Publication, the COR shall notify the Contractor and the NIAID Contracting Officer. The COR is responsible for ensuring that all parties adhere to the terms and conditions of any existing Material Evaluation Agreement or other appropriate document between NIAID and the Supplier. NIAID will use its best efforts to assist and expedite the review process by the Supplier.

Should patents arise from this contract, they shall be subject to federal law governing inventions. Every patent applicant (individual or institutional) is required to provide the Government with a non-exclusive, irrevocable, paid-up license to the invention.

135 USC 201(e): The term ''subject invention'' means any invention of the contractor conceived or first actually reduced to practice in the performance of work under a funding agreement: Provided, that in the case of a variety of plant, the date of determination (as defined in section 41(d) of the Plant Variety Protection Act (7U.S.C. 2401(d)) must also occur during the period of contract performance.

Invoice Processing Platform (IPP) NIH is using a phased transition approach from the NIH Office of Financial Management (OFM) Electronic Invoice Submission instructions to the Department of Treasury’s Invoice Processing Platform (IPP). This award will transition to IPP in the future. The Contractor/Vendor shall use the attached NIH OFM Electronic Invoice Submission Instructions until the Contractor/Vendor has transitioned to IPP as specified on the OALM IPP website at https://oalm.od.nih.gov/IPP. It is the Contractor/Vendor’s responsibility to periodically check the OALM IPP website and be prepared to transition to IPP on the designated transition date. Questions concerning the transition to IPP should be directed to NIH-IPPinvoicing@mail.nih.gov. Questions concerning this award should be directed to the NIH Contracting Officer.

All IPP invoices must contain a Unique Entity Identifier (UEI) which is located in the System for Award Management (SAM) and replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number.

https://oalm.od.nih.gov/IPP file://///niaid-fas2/cmbsh/DAIT%20Research%20Contracts%20Branch/SOLICITATIONS/FY2027/IB2731%20Development%20of%20MCMs%20and%20BD%20-%20BAA%20-%20LISA/Tab%20D%20-%20Solicitation/Solicitation/NIH-IPPinvoicing@mail.nih.gov

SECTION C - Description/Specifications/Work Statement

1. STATEMENT OF WORK

Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, dated TBD, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

Offeror(s) are required to develop their own SOW based on the information provided in the Attachment titled, "Research and Technical Objectives." Offeror(s) are advised to limit the amount of proprietary data or markings in their SOW. The final negotiated SOW will be incorporated into the contract upon award and may be subject to release to the public. If the SOW does include proprietary data or markings, offeror(s) are advised to clearly mark these portions and provide an explanation why this data/marking is proprietary."

2. REPORTING REQUIREMENTS

All reports shall be submitted electronically.

These reports shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: https://www.hhs.gov/web/section-508/index.html and at:

https://www.section508.gov/create/documents , "Create Accessible Documents."

a. Technical Progress Reports

In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award. [Note: Beginning May 25, 2008, the Contractor shall include the applicable PubMed Central or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.]

For proposal preparation purposes only, it is estimated that in addition to the required electronic version(s) hard copies of these reports will be required as follows:

[ ] Monthly

[X] Quarterly

[ ] Semi-Annually

[] Annually

[X] Annually (with a requirement for a Draft Annual Report)

[ ] Final - Upon final completion of the contract

[X] Final - Upon final completion of the contract (with a requirement for a Draft Final Report)

b. Summary of Salient Results

The Contractor will be required to prepare and submit, with the final report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract. This report will be required on or before the expiration date of the contract.

c. Other Reports/Deliverables

1. Reporting of Financial Conflict of Interest (FCOI)

All reports and documentation required by 45 CFR Part 94, Responsible Prospective Contractors including, but not limited to, the New FCOI Report, Annual FCOI Report, Revised FCOI Report, and the Mitigation Report, shall be submitted to the Contracting Officer in [Electronic/Hard Copy] format.

Thereafter, reports shall be due in accordance with the regulatory compliance requirements in 45 CFR Part 94. 45 CFR Part 94 is available at: https://www.ecfr.gov/current/title-45/part-94.

See Part 94.5, Responsibilities of Institutions regarding Investigator financial conflicts of interest for complete information on reporting requirements.

(Reference the INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST Article in SECTION H of this contract.)

2. Section 508 Annual Report

The Contractor must submit an annual Section 508 report in accordance with the schedule set forth by the Contracting Officer (CO)/Contracting Officer's Representative (COR). The Section 508 Report Template and Instructions for completing the report are available at:

https://www.hhs.gov/sites/default/files/web/508/contracting/technology/section_508_annual_repor t.doc.

https://www.hhs.gov/sites/default/files/web/508/contracting/technology/section_508_annual_report.doc https://www.hhs.gov/sites/default/files/web/508/contracting/technology/section_508_annual_report.doc

3. Multiple Principal Investigators Leadership Plan

The Contractor must submit a revised/updated Leadership Plan in the event of a change in any of the Principal Investigators named in the Key Personnel Article in SECTION G of this contract. The revised plan is subject to review and approval by the Contracting Officer.

4. REPORTING REQUIREMENTS FOR USE WITH THE ELECTRONIC REPORT DELIVERABLE

SUBMISSION (eRDS) SITE

All reports required herein must be submitted in electronic format. All electronic contract deliverables must be submitted via the NIAID electronic Report Deliverable Submission (eRDS) Site, available at the following website: https://erds.niaid.nih.gov/ . All electronic reports submitted must be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at https://www.hhs.gov/web/section-508/index.html and at:

https://www.section508.gov/create/documents , 'Create Accessible Documents.'

3. INVENTION REPORTING REQUIREMENT

All reports and documentation required by [FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor/FAR Clause 52.227-13, Patent Rights-Ownership by the Government] including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Division of Extramural Inventions and Technology Resources (DEITR), OPERA, OER, NIH, 6705 Rockledge Drive, Suite 310, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986). In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract.

The annual utilization report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract. All reports shall be sent to the following address:

Contracting Officer National Institutes of Health National Institutes of Allergy and Infection Diseases Office of Acquisition 5601 Fishers Lane, Room 3D10 Bethesda, Maryland 20892

If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer at the address listed above.

To assist contractors in complying with invention reporting requirements of the clause, the NIH has developed "Interagency Edison," an electronic invention reporting system. Use of Interagency Edison is required as it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted is protected. Interagency Edison and information relating to the capabilities of the system can be obtained from the Web ( http://www.iedison.gov ), or by contacting the Extramural Inventions and Technology Resources Branch, OPERA, NIH.

SECTION D – Packaging, Marking, and Shipping

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

SECTION E - Inspection and Acceptance

a. The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

b. For the purpose of this SECTION, the Contracting Officer’s Representative is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Institutes of Health National Institute of Allergy and Infectious Diseases Division of Allergy, Immunology, and Transplantation 5601 Fishers Lane Bethesda, Maryland 20852.

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.

d. This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

FAR 52.246-9 Inspection of Research and Development (Short Form). (APR 1984)

SECTION F - Deliveries or Performance

1. PERIOD OF PERFORMANCE

a. The period of performance of this contract shall be from TBD through TBD.

b. If the Government exercises its options pursuant to the OPTION PROVISION Article in Section H of this contract, the period of performance will be increased as listed below:

Option Option Period

Option Period 1 TBD

Option Period 2 TBD

2. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Work Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule:

a. The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract will be required to be delivered F.o.b. Destination as set forth in FAR 52.247-35, F.o.b.

DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the date(s) specified in Attachment 4 and specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this contract.

b. All reports required herein shall be submitted in electronic format. All electronic contract deliverables shall be submitted via eRDS (NIAID's electronic Report Deliverable Submission), available at the following website: http://erds.niaid.nih.gov/. Attachment 24, eRDS Vendor Quick Reference is attached in Section J of the contract.

3. FAR 52.252-2 Clauses Incorporated by Reference. (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address: https://www.acquisition.gov/?q=browsefar

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989)

Alternate I (April 1984) is applicable to this contract.

https://www.acquisition.gov/?q=browsefar

SECTION G - Contract Administration Data

1. CONTRACTING OFFICER REPRESENTATIVE (COR)

The following Contracting Officer Representative (COR) will represent the Government for the purpose of this contract:

To be specified in the contract award.

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract

The Government may unilaterally change its COR designation.

2. KEY PERSONNEL, HHSAR 352.237-75 (DEC 2015)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

(End of clause)

The following individual(s) [is/are] considered to be essential to the work being performed hereunder:

Name Title

TBD TBD

3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL

REPORT

a. Invoice Submission, NIH(RC)-4 for NIH Cost-Reimbursement Type Contracts are attached and made part of this contract. The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

1. The Contractor must submit invoices to the Department of Treasury's Invoice Processing Platform (IPP) at https://www.ipp.gov with a copy of the invoice to the approving official, as directed below.

2. Until the Contract has transitioned to IPP as specified on the OALM IPP website, the Contractor must follow step-by-step instructions as stated in the NIH/OFM Electronic Invoicing Instructions for NIH Contractors/Vendors, which is included as an attachment in Section J of this contract. The invoice submitted to the NIH/OFM must be transmitted as an attachment via email to the address listed above in one of the following formats: Word, or Adobe Portable Document Format (PDF). The Contractor must submit only one invoice per email. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your invoice unless specified elsewhere in the contract or requested by the Contracting Officer.

3. The Contractor shall submit a copy of the electronic invoice to the following Approving Official (Contracting Officer) and Contracting Officer Representative:

Official: Contracting Officer

Name- TBD

Contracting Officer Representative

Name- TBD Email Address- TBD

For inquiries regarding the status of invoices, contact OFM Customer Service via email at ofm_customer_service@mail-cmp.niceincontact.com or via phone at 301-496-6088. To send your inquiries via other available communication methods refer to the OFM Customer Service website at https://ofm.od.nih.gov/Pages/Customer-Service.aspx .

https://www.ipp.gov/ https://ofm.od.nih.gov/Pages/Customer-Service.aspx

Note: The OFM Customer Service is open Eastern Standard Time Monday - Friday from 8:30 a.m. to 5:00 p.m. and is closed between 12:00 p.m. to 1:00 p.m.

4. In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall include the following information on the face page of all payment requests:

a. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is National Institute of Allergies and Infectious Diseases (NIAID).

b. Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall identify the Vendor Identification Number (VIN) on the payment request.

The VIN is the number that appears after the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, Unique Entity Identifier (UEI), or VIN, contact the Contracting Officer.

Note: The Contractor shall not include TIN if it is a Social Security Number.

c. Unique Entity Identifier (UEI). The UEI is located in the System for Award Management (SAM) and replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number. The UEI number must identify the Contractor's name and address exactly as stated in the contract and as registered in the Central Contractor Registration (CCR) database. If the Contractor does not have a valid UEI number, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract.

[Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, UEI, or VIN, contact the Contracting Officer.

d. Invoice Matching Option. This contract requires a two-way match.

e. Unique Invoice Number. Each payment request must be identified by a unique invoice number, which can only be used one time regardless of the number of contracts or orders held by an organization.

f. The Contract Title is: To be specified in the contract.

g. Contract Line Items as follows:

Line Item # Line Item Description

TBD TBD

b. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496- 6088.

c. The Contractor shall include the following certification on every invoice for reimbursable costs incurred with Fiscal Year funds subject to HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of this contract. For billing purposes, certified invoices are required for the billing period during which the applicable Fiscal Year funds were initially charged through the final billing period utilizing the applicable Fiscal Year funds:

'I hereby certify that the salaries charged in this invoice are in compliance with HHSAR Clause 352.231- 70, Salary Rate Limitation in SECTION I of the above referenced contract.'

4. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR

52.232-40 (Mar 2023).

(a) (1) In accordance with 31 U.S.C. 3903 and 10 U.S.C. 3801, within 15 days after receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

(2) The Contractor agrees to make such payments to its small business subcontractors without any further consideration from or fees charged to the subcontractor.

(b) The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act.

(c) Include the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial products or commercial services.

(End of clause).

5. INDIRECT COST RATES

In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Clause 52.216-7 (d)(2), Allowable Cost and Payment incorporated by reference in this contract in PART II, SECTION I, the cognizant Contracting Officer Representative responsible for negotiating provisional and/or final indirect cost rates is identified as follows:

Director, Division of Financial Advisory Services Office of Acquisition Management and Policy National Institutes of Health

6011 EXECUTIVE BLVD, ROOM 549C, MSC-7663

BETHESDA MD 20892-7663

These rates are hereby incorporated without further action of the Contracting Officer. Go to the Indirect Cost Submission web page: https://oamp.od.nih.gov/division-of-financial-advisory-services/indirect-cost-branch/indirect-cost-submission for electronic copies of the Branch's information package documents.

6. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

Interim and Final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The Final performance evaluation will be prepared at the time of completion of work. In addition to the Final evaluation, Interim evaluation(s) will be prepared Annually.

Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted sixty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

a. Electronic Access to Contractor Performance Evaluations

Contractors may access evaluations through a secure Web site for review and comment at the following address:

https://www.cpars.gov.

End of clause.

https://oamp.od.nih.gov/division-of-financial-advisory-services/indirect-cost-branch/indirect-cost-submission https://oamp.od.nih.gov/division-of-financial-advisory-services/indirect-cost-branch/indirect-cost-submission https://www.cpars.gov/

7. GOVERNMENT PROPERTY

If this RFP will result in the acquisition or use of Government Property provided by the contracting agency or if the Contracting Officer authorizes in the preaward negotiation process, the acquisition of property (other than real property), this ARTICLE will include applicable provisions and incorporate the HHS Publication, entitled, 'HHS Contracting Guide for Contract of Government Property,' Appendix Q, which can be found at:

https://oamp.od.nih.gov/sites/default/files/DGS/HHS%20Contracting%20Guide%20for%20Contract%20of%2 0Government%20Property-Appendix%20Q.pdf

SECTION H - Special Contract Requirements

1. PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4(b) (December 2015).

a. The Contractor agrees that the rights and welfare of human subjects involved in research under this contract shall be protected in accordance with 45 CFR part 46 and with the Contractor's current

Federal-wide Assurance (FWA) on file with the Office for Human Research Protections (OHRP), Department of Health and Human Services. The Contractor further agrees to provide certification at least annually that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects in accordance with 45 CFR part 46 and the Assurance of Compliance.

b. The Contractor shall bear full responsibility for the performance of all work and services involving the use of human subjects under this contract and shall ensure that work is conducted in a proper manner and as safely as is feasible. The parties hereto agree that the Contractor retains the right to control and direct the performance of all work under this contract. Nothing in this contract shall create an agency or employee relationship between the Government and the Contractor, or any subcontractor, agent or employee of the Contractor, or any other person, organization, institution, or group of any kind whatsoever. The Contractor agrees that it has entered into this contract and will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as an independent Contractor without creating liability on the part of the Government for the acts of the Contractor or its employees.

c. Contractors involving other agencies or institutions in activities considered to be engaged in research involving human subjects must ensure that such other agencies or institutions obtain their own FWA if they are routinely engaged in research involving human subjects or ensure that such agencies or institutions are covered by the Contractors' FWA via designation as agents of the institution or via individual investigator agreements (see OHRP Website at: https://www.hhs.gov/ohrp/index.html ).

d. If at any time during the performance of this contract the Contractor is not in compliance with any of the requirements and or standards stated in paragraphs (a) and (b) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. The Contracting Officer may communicate the notice of https://oamp.od.nih.gov/sites/default/files/DGS/HHS%20Contracting%20Guide%20for%20Contract%20of%20Government%20Property-Appendix%20Q.pdf https://oamp.od.nih.gov/sites/default/files/DGS/HHS%20Contracting%20Guide%20for%20Contract%20of%20Government%20Property-Appendix%20Q.pdf suspension by telephone with confirmation in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer's written notice of suspension, the Contracting Officer may, after consultation with OHRP, terminate this contract in whole or in part.

(End of clause).

2. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

NIH policy requires education on the protection of human subject participants for all investigators receiving NIH contract awards for research involving human subjects. For a complete description of the NIH Policy announcement on required education in the protection of human subject participants, the Contractor should access the NIH Guide for Grants and Contracts Announcement dated August 25, 2000 at the following website:

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

The information below is a summary of the NIH Policy Announcement:

The Contractor shall maintain the following information: (1) a list of the names and titles of the principal investigator and any other individuals working under the contract who are responsible for the design and/or conduct of the research; (2) the title of the education program(s) in the protection of human subjects that has been completed for each named personnel and; (3) a one sentence description of the educational program(s) listed in (2) above. This requirement extends to investigators and all individuals responsible for the design and/or conduct of the research who are working as subcontractors or consultants under the contract.

Prior to any substitution of the Principal Investigator or any other individuals responsible for the design and/or conduct of the research under the contract, the Contractor shall provide the following written information to the Contracting Officer: the title of the education program and a one sentence description of the program that has been completed by the replacement.

3. CERTIFICATE OF CONFIDENTIALITY

Section 2012 of the 21st Century Cures Act, enacted December 13, 2016, enacts new provisions governing the authority of the Secretary of Health and Human Services (Secretary) to protect the privacy of individuals who are the subjects of research, including significant amendments to the previous statutory authority for such protections, under subsection 301(d) of the Public Health Service Act.

Effective October 1, 2017, all research that was commenced or ongoing on or after December 13, 2016 and is within the scope of the NIH Policy for Issuing Certificate of Confidentiality (CoC) NOT-OD-17-109, the Contractor shall protect the privacy of individuals who are subjects of such research in accordance with subsection 301(d) of the Public Health Service Act as a term and condition of the contract. The certificate will not be issued as a separate document.

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html

NIH considers research in which identifiable, sensitive information is collected or used, to include:

• Human subjects research as defined in the Federal Policy for the Protection of Human Subjects (45 CFR 46), including exempt research (except for human subjects' research that is determined to be exempt from all or some of the requirements of 45 CFR 46) if the information obtained is recorded in such a manner that human subjects cannot be identified or the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects);

• Research involving the collection or use of biospecimens that are identifiable to an individual or for which there is at least a very small risk that some combination of the biospecimen, a request for the biospecimen, and other available data sources could be used to deduce the identity of an individual;

• Research that involves the generation of individual level, human genomic data from biospecimens, or the use of such data, regardless of whether the data is recorded in such a manner that human subjects can be identified or the identity of the human subjects can readily be ascertained as defined in the Federal Policy for the Protection of Human Subjects (45 CFR 46); or

• Any other research that involves information about an individual for which there is at least a very small risk, as determined by current scientific practices or statistical methods, that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual, as defined in subsection 301(d) of the Public Health Service Act.

The Contractor shall not:

• Disclose or provide, in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding, the name of such individual or any such information, document, or biospecimen that contains identifiable, sensitive information about the individual and that was created or compiled for purposes of the research, unless such disclosure or use is made with the consent of the individual to whom the information, document, or biospecimen pertains; or

• Disclose or provide to any other person not connected with the research the name of such an individual or any information, document, or biospecimen that contains identifiable, sensitive information about such an individual and that was created or compiled for purposes of the research.

The Contractor is permitted to disclose only in below circumstances. The Contractor shall notify the CO minimum ten (10) calendar days prior to disclosure.

• Required by Federal, State, or local laws (e.g., as required by the Federal Food, Drug, and Cosmetic Act, or state laws requiring the reporting of communicable diseases to State and local health departments), excluding instances of disclosure in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding;

• Necessary for the medical treatment of the individual to whom the information, document, or biospecimen pertains and made with the consent of such individual;

• Made with the consent of the individual to whom the information, document, or biospecimen pertains; or

• Made for the purposes of other scientific research that is in compliance with applicable Federal regulations governing the protection of human subjects in research.

In accordance with 45 CFR Part 75.303(a), the Contractor shall maintain effective internal controls (e.g., policies and procedures) that provide reasonable assurance that the award is managed in compliance with Federal Statutes and regulations.

The recipient of CoCs shall ensure that any company/institution/individual not funded by NIH who receives a copy of identifiable, sensitive information protected by a Certificate understand that they are also subject to the requirements of subsection 301(d) of the Public Health Service Act. The Contractor shall ensure that Subcontractors who receive funds to carry out part of the Federal award understand they are also subject to subsection 301(d) of the Public Health Service Act and the NIH Policy for Issuing CoC.

4. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

NIH-conducted and supported clinical research must conform to the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research in accord with Public Health Service Act sec. 492B, 42 U.S.C. sec. 289a-2. The policy requires that women and members of minority groups and their subpopulations must be included in all NIH-conducted or supported clinical research projects involving human subjects, unless a clear and compelling rationale and justification establishes to the satisfaction of the relevant NIH Institute/Center (IC) Director that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. The Director, NIH, may determine that exclusion under other circumstances is acceptable, upon the recommendation of an IC Director, based on a compelling rationale and justification. Cost is not an acceptable reason for exclusion except when the study would duplicate data from other sources. Women of childbearing potential should not be routinely excluded from participation in clinical research.

All investigators proposing research involving human subjects should read the UPDATED "NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, Amended November 2017," published in the NIH Guide for Grants and Contracts on October 9, 2001 at the following web site:

https://grants.nih.gov/policy/inclusion/women-and-minorities/guidelines.htm.

The Contractor must submit the results of valid analyses by sex/gender and race/ethnicity to Clinicaltrials.gov for all NIH-conducted or supported applicable NIH-defined Phase III clinical trials. This requirement does not apply to NIH-defined Phase III trials not considered to applicable clinical trials under 42 CFR Part 11. The Contractor must report applicable NIH-defined Phase III clinical trials involving research subjects of all ages, https://grants.nih.gov/policy/inclusion/women-and-minorities/guidelines.htm including foreign awards and domestic awards with a foreign component. The Contractor must specify outcomes on sex/gender and race/ethnicity, as required based on prior evidence, and as explained in the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research.

Note: Applicable clinical trials are required to be registered in ClinicalTrials.gov not later than 21 calendar days after the enrollment of the first participant.